Insecticidal School Uniforms for Dengue Prevention in Thailand (DengueTools)

August 31, 2015 updated by: Peter Byass, Umeå University

Can Insecticide-treated School Uniforms Reduce Dengue Infections in School-aged Children in Thailand

This is a randomised controlled trial that will be conducted in eastern Thailand in a group of schools with approximately 2,000 students aged 7-15 years. Pre-fabricated school uniforms will be commercially treated to ensure consistent high quality of insecticide impregnation with permethrin. A double-blind randomised cross-over trial at the school level will cover two dengue transmission seasons.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1825

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Salaya, Thailand
        • Centre of Excellence for Vectors and Vector-Borne Diseases, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 15 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • pupils in participating schools

Exclusion Criteria:

  • skin sensitivity, exema

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: normal school uniforms
washing only
Other: washing
normal washing of school uniforms, without permethrin insecticide impregnation
EXPERIMENTAL: insecticide-treated school uniforms
washing and insecticide treatment
Other: permethrin insecticide
commercial permethrin insecticide impregnation of clothing before transmission season

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
insecticide:placebo incidence rate-ratio (per 1,000 person-years) of laboratory-confirmed dengue cases in school-aged children
Time Frame: up to 2 years
Schools are cross-over randomised to insecticide-treated or untreated (placebo) school uniforms, and so the primary outcome is the rate-ratio of dengue fever cases in school children, compared between these two groups.
up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
comparison between intervention and placebo groups of number of serious skin reactions to insecticide-treated uniforms
Time Frame: up to 2 years
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Collaborators

European Union

Investigators

  • Principal Investigator: Annelies Wilder-Smith, MD, Umea University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

March 16, 2012

First Submitted That Met QC Criteria

March 22, 2012

First Posted (ESTIMATE)

March 27, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 1, 2015

Last Update Submitted That Met QC Criteria

August 31, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 282589-T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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